Trial record 1 of 1 for: NCT00305903

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Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00305903

Recruitment Status : Completed

First Posted : March 22, 2006

Last Update Posted : December 21, 2007

Sponsor:

Information provided by:

Novartis

Study Description

Brief Summary:

This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Rivastigmine, memantine	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)
Study Start Date :	March 2006
Actual Study Completion Date :	August 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Memantine Memantine hydrochloride Rivastigmine Rivastigmine tartrate

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)

Secondary Outcome Measures :

Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a diagnosis of probable Alzheimer's disease;
Have an MMSE score between 10 and 20;
Must be able to swallow capsule/tablet;
Must have a caregiver who is able to attend all study visits;

Exclusion Criteria:

Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
Have a current diagnosis of active, uncontrolled seizure disorder;
Have a history within the past year or current diagnosis of cerebrovascular disease
Have a current diagnosis of severe or unstable cardiovascular disease;
Had a myocardial infarction (MI) within the last six months;
Have specific respiratory, digestive, renal, or endocrine disorders;
Have had previous treatment with rivastigmine or memantine;

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305903

Locations

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United States, New Jersey

Manchester, New Jersey, United States, 08759

Sponsors and Collaborators

Novartis

Investigators

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Study Chair:	Novartis	862-778-8300

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sadowsky CH, Dengiz A, Meng X, Olin JT; US38 Study Group. Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results. Prim Care Companion J Clin Psychiatry. 2010;12(5). pii: PCC.09m00852. doi: 10.4088/PCC.09m00852oli.

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ClinicalTrials.gov Identifier:	NCT00305903
Other Study ID Numbers:	CENA713BUS32
First Posted:	March 22, 2006 Key Record Dates
Last Update Posted:	December 21, 2007
Last Verified:	December 2007

Keywords provided by Novartis:


Dementia, Alzheimer's, Rivastigmine, Memantine

Additional relevant MeSH terms:

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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Memantine Rivastigmine Antiparkinson Agents	Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents Neuroprotective Agents Protective Agents

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